雷贝拉唑在消化性溃疡治疗中的作用及其安全性的大规模临床研究

目的观察雷贝拉唑片剂(波利特)单独应用或联合抗幽门螺杆菌(Hp)治疗对消化性溃疡患者主要症状的治疗作用及其安全性。方法在全国24个省市进行多中心、开放试验。经胃镜诊断为消化性溃疡活动期或愈合期的患者由医师根据其具体情况安排单独应用雷贝拉唑(10mg,每天1次,7d)或联合抗Hp治疗(其中雷贝拉唑为10mg,每天2次,每个疗程5d或7d)。观察治疗前(d0)、用药后第1(d1)、2(d2)、5(d5)和7天(d7)的症状,并记录不良反应。结果试验共入选患者25609例,其中包括胃溃疡、十二指肠溃疡、复合性溃疡、食管溃疡、应激性溃疡、吻合口溃疡。Hp总体阳性率为71.0%。单独用雷贝拉唑者11386例,联合用药14223例。在d1、d2、d5和d7,上腹痛的缓解率分别为63.0%、91.2%、99.2%和99.7%;消失率为16.0%、47.8%、80.3%及94.8%。总体症状缓解率分别为66.5%、94.6%、99.7%和99.9%。上述指标在两组之间比较差异均无统计学意义。共发生不良反应476例(1.9%)。单独用药组147例(1.3%),联合用药组329例(2.3%),两组间比较差异有非常显著意义(P<0.01)。多数不良反应轻微。结论雷贝拉唑在单独用药及与抗Hp药物合用时,对消化性溃疡患者的主要症状都具有明显的治疗作用,并具有良好的安全性。

The clinical applications of rabeprazole either alone or combined with anti-Helicobacter pylori agents in peptic ulcer patients

OBJECTIVE: To study the efficacy and safety of rabeprazole in peptic ulcer patients alone or combined with anti-Helicobacter pylori (Hp) agents. METHODS: An open labeled multi-center clinical trial was designed. Different types peptic ulcer patients identified by endoscopy were recruited from 24 provinces and cities in China. They were given rabeprazole alone 10 mg/d for 7 days continuously (rabeprazole alone group), or combined anti-Hp protocol (including rabeprazole 10 mg, b.i.d., 5 or 7 days) (combination group) respectively by doctors according to their disease situations. Their symptoms and side effects during the therapy were recorded. RESULTS: This study included 25 609 patients in total with 11 386 in rabeprazol alone group and 14 223 in combination and following diseases as gastric ulcer, duodenal ulcer, complex ulcer, esophageal ulcer, stress ulcer and anastomotic ulcer. The effective rates relieving epigastric pain was 63.0%, 91.2%, 99.2% and 99.7%, respectively, with elimination rates of 16.0%, 47.8%, 80.3%, 94.8%, respectively on the 1st, 2nd, 5th and 7th day. The effective rate to relieve all symptoms on the 1st, 2nd, 5th and 7th day was 42.0%, 78.0%, 93.1% and 98.3%. No statistical differences between rabeprazole alone group and combined group. 476 patients (1.9%) developed mild side effects during the therapy, labeprazole alone group of 147 (1.3%), and combined group of 329 (2.3%), P < 0.01. No severe side effects occurred. CONCLUSIONS: Whether labeprazole was used alone or combined with anti-Hp agents, it is an effective and safe therapy for the treatment of peptic ulcer.